Pharmacovigilance Analyst
Pharmacovigilance Analyst
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Job Description
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Primary Duties and Responsibilities:
- Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE) Medical Device Incident (MDI) information from the source document
- Accountable for Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage Duplicate Search Data Entry MedDRA codding Narrative Writing Medical Evaluation Seriousness assessment expectedness assessment Causality assessment Reportability Assessment Expedite and Periodic submission etc.
- Accountable to perform Literature Review as per the applicable organizations SOP and WI
- Accountable preparation and/or review of aggregate reports as per applicable SOP and WI including but not limited to Annual Summary Reports (ASR) Issue Related Summary Report (IRSR) Periodic Safety Update Reports (PSURs) Periodic Benefit-Risk Evaluation Report (PBRERs) Periodic Adverse Drug Experience Report (PADER) Developmental Safety Update Report (DSUR) etc.
- Accountable for performing Signal Detection as per applicable SOP and WI Accountable for preparation and/or update of Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategies (REMS) and associated documents
- Accountable to act as a contact point for the client Work directly with internal and external stakeholders to request additional information or clarification as necessary;
- Assist in audit preparation File and store all documents as per applicable SOP and WI.
- Other tasks assigned by the Manager as needed. May be required to be on standby / on-call as part of this role.
Experience and Educational Requirements:
- Bilingual English/French strongly preferred
- Bachelors degree in a Pharmacy Dental Pharmacology Nursing or Medical Degree
- 3-4 years of experience in the Pharmacovigilance area of the pharmaceutical industry; Knowledge of medical terminology is a strong asset
Minimum Skills Knowledge and Ability Requirements:
- Strong knowledge of the pharmacovigilance industry including up-to-date knowledge of Health Canada US-FDA and ICHs
- Pharmacovigilance requirements and guidelines
- Familiarity with MS Word MS Excel MS PowerPoint other MS Office Programs and Adobe Pro
- Familiarity with Good Documentation Practice (GDP) and Quality Management Systems (QMS) is an asset
- Strong business and financial acumen
- Strong analytical and mathematical skills
- Ability to communicate effectively both orally and in writing
- Effective interpersonal and leadership skills
- Effective organizational skills attention to details
- Ability to consistently meet deadlines
- Excellent problem-solving skills; ability to resolve issues effectively and efficiently
- Excellent presentation skills
- Able to work any 8-hour shift between 8:00 AM-8 PM if necessary
- Can-do attitude with proven ability to meet strict deadlines
What Cencora offers
We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every day. In addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more.
Full timeEqual Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.
The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Accessibility Policy
Cencora is committed to fair and accessible employment requested Cencora will accommodate people with disabilities during the recruitment assessment and hiring processes and during employment.
Affiliated Companies:
Affiliated Companies: Innomar StrategiesRequired Experience:
IC
Employment Type
Full-Time
